FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL (POLIGLECAPRONE 25) SUTURE
MDR report key: 1911382
·
Received November 24, 2010
Report
- Report Number
- 2210968-2010-01603
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 29, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K960653
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A HEMORRHOIDECTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE SWAGE DURING CONTINUOUS SUTURING AT THE ANUS. NO FRAGMENT REMAINED IN THE PT'S BODY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOCRYL (POLIGLECAPRONE 25) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | CEM729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |