FDA Adverse Event
Malfunction
Summary report: N
TEMPORARY PACKING WIRE
MDR report key: 881314
·
Received October 20, 2004
Report
- Report Number
- 2210968-2004-00522
- Event Type
- Malfunction
- Date Received
- October 20, 2004
- Date of Event
- September 2, 2004
- Report Date
- September 21, 2004
- Manufacturer
- ETHICON, INC.
- Product Code
- GAO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE LOT NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE LOT NUMBERS: PRODUCT CODE: TP240, LOT NUMBER: SHH048, MANUFACTURE DATE: 07/14/2003, EXPIRATION DATE: 01/31/2008; PRODUCT CODE: TPW40, LOT NUMBER: RLJ124, MANUFACTURE DATE: 11/05/2002, EXPIRATION DATE: 07/31/2007. CONCLUSION CODE: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN REC'D, HOWEVER, THE PRODUCT EVALUATION NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTED THE DEVICE WAS NOT PACING PROPERLY. NO ADVERSE PT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPORARY PACKING WIRE | SUTURE, NON-ABSORBABLE | GAO | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |