FDA Adverse Event
Injury
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 2071007
·
Received April 27, 2011
Report
- Report Number
- 2210968-2011-00520
- Event Type
- Injury
- Date Received
- April 27, 2011
- Report Date
- April 1, 2011
- Manufacturer
- ETHICON, INC.
- Product Code
- NEW
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE. POST-OPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISENCE AND UNDERWENT RE-OPERATION. THE SURGEON REPORTED THAT THE SUTURE HAD SPLICED LENGTHWISE. ADDITONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURE, ABSORBABLE | NEW | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |