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Adverse Event Report

ETHICON, INC. SAN ANGELO PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE   back to search results
Catalog Number Z880G
Device Problem Suture line separation
Event Date 09/05/1999
Event Type  Injury  
Manufacturer Narrative

Date sent to fda: 03/23/2000. D6: the user facility reported that it is not possible to identify a specific suture lot involved in this event. Numerous additional lot numbers were reported to be within the surgical facility and store room including lots that were not mfg at the reported time of surgery. Accordingly, the actual lot involved is unknown. Conclusions: it cannot be determined what role, if any, the device played in the event described. Numerous attempts to obtain this info from the user facility were unsuccessful. Several attempts were made to obtain user facility report number. Attempts to clarify discrepancy between b3 and f6 were unsuccessful. No info was provided.

 
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Brand NamePDS II (POLYDIOXANONE) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Brand NamePDS II (POLYDIOXANONE) SUTURE
Baseline Generic NameABSORBABLE SUTURE
Baseline Catalogue NumberZ880G
Baseline Device FamilyPDS II (POLYDIOXANONE) SUTURE
Baseline Device 510(K) Number
Baseline Device PMA NumberN18331
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed11/11/1981
Manufacturer (Section F)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer (Section D)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer Contact
berkley pollard
route 22 west
po box 151
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key262692
MDR Report Key271361
Event Key254407
Report Number2210968-2000-00052
Device Sequence Number1
Product CodeGAN
Report Source Manufacturer
Source Type User facility
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2000
Device Operator Invalid Data
Device Catalogue NumberZ880G
Date Manufacturer Received02/25/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

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