MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-23 for DEROYAL 32-1622 manufactured by G.a. Surgical (pvt) Ltd.
[4171787]
The medical center reported that the gomco bells seem to be defective. They have been experiencing an increase in newborns bleeding post circumcision because the bell does not clamp properly.
Patient Sequence No: 1, Text Type: D, B5
[11521535]
Describe event or problem: the medical center reported that the gomco bells seem to be defective. They have been experiencing an increase in newborns bleeding post circumcision because the bell does not clamp properly. Deroyal: the supplier's investigation determined that lots were built out of specification, resulting in the potential for the device to not clamp the surgical site properly. Deroyal had made a one time purchase from (b)(4) and has determined to conduct a voluntary recall of all products purchased from them. Any product remaining in inventory has been quarantined for destruction, and initial recall letters have been sent to affected customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320762-2014-00001 |
| MDR Report Key | 3608591 |
| Report Source | 06 |
| Date Received | 2014-01-23 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-12-20 |
| Date Facility Aware | 2013-12-20 |
| Report Date | 2013-12-20 |
| Date Reported to Mfgr | 2013-12-20 |
| Date Mfgr Received | 2013-12-20 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-02-06 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | COURTNEY RINEHART |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622122 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | FHA - CLAMP, PENILE |
| Product Code | FHA |
| Date Received | 2014-01-23 |
| Catalog Number | 32-1622 |
| Lot Number | 33444071 |
| Device Expiration Date | 2018-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | G.A. SURGICAL (PVT) LTD |
| Manufacturer Address | SIALKOT 51310 PK 51310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-23 |