FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL (POLIGLECAPRONE 25) SUTURE
MDR report key: 3950382
·
Received July 22, 2014
Report
- Report Number
- 2210968-2014-09802
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Date of Event
- May 1, 2014
- Report Date
- July 2, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAN
- PMA / PMN Number
- K964072
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: RETAINED SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE EVALUATED FOR PACKAGING INTEGRITY, SEALS STRENGTH, AND SEAL WIDTH. ALL DEVICES MET SPECIFICATION.
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2014, THE DEVICE WAS RECEIVED IN AN UNSEALED CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428320 | MONOCRYL (POLIGLECAPRONE 25) SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAN | ETHICON INC. | UNK | T3024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |