MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-09-09 for GENTLE TOUCH SYS 100MM WITH LOOP OSTOMY ROD 020934 manufactured by Convatec, A Division Of E.r. Squibb & Sons L.l.c..
[3747313]
Operating room manager with unity health system reports that this morning a surgeon opened a gentle touch loop ostomy system in the operating room, and just prior to inserting the rod, the swivel tip snapped off. The rod had no contact with the patient. Both pieces are to be returned along with the gentle touch package.
Patient Sequence No: 1, Text Type: D, B5
[11171455]
The loop rod sample was broken along the long axis. (b)(4) was raised. The retain sample was examined. Components were present, assembled properly and consistent with product specification requirements. There was no evidence of any mfg defect. Components used were approved for use. The loop rod was examined and the swivel end checked. The swivel end was rotated 10 cycles and each time clicked to correct location with no evidence of any stress to the swivel or loop rod. The batch record review found no objective evidence of discrepancies related to the complaint issue. Case was identified during a recent fda facility inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00008 |
| MDR Report Key | 3371524 |
| Report Source | 05,06,07 |
| Date Received | 2013-09-09 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-06-10 |
| Date Mfgr Received | 2011-06-10 |
| Date Added to Maude | 2013-12-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Manufacturer G1 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTLE TOUCH SYS 100MM WITH LOOP OSTOMY ROD |
| Generic Name | ROD, COLOSTOMY |
| Product Code | EZP |
| Date Received | 2013-09-09 |
| Returned To Mfg | 2011-07-28 |
| Model Number | 020934 |
| Catalog Number | 020934 |
| Lot Number | OH02364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-09 |