MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-01-14 for AMNIHOOK AMNIOTIC MEMBRANE D9601 manufactured by Hollister Inc.
[20109007]
It was reported that two infants were found with 1/4" to 1/2" long scabbed lacerations of their scalp. Both infants were born to mothers who had amniotomies performed with amnihooks and no internal monitoring. These lacerations were significant and assessed throughout hospitalization by the covering pediatrician. The occurrences were with two different doctors. A returned sample was inspected by the mfr, during which it was determined that the unit was normal and function. During manufacture, the units are 100% inspected for potential issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219232-2012-00009 |
| MDR Report Key | 3244599 |
| Report Source | 99 |
| Date Received | 2013-01-14 |
| Date of Report | 2013-01-11 |
| Date of Event | 2012-12-06 |
| Date Facility Aware | 2012-12-10 |
| Report Date | 2013-01-11 |
| Date Reported to FDA | 2013-01-11 |
| Date Reported to Mfgr | 2013-01-11 |
| Date Added to Maude | 2013-07-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNIHOOK AMNIOTIC MEMBRANE |
| Generic Name | AMNIHOOK |
| Product Code | HGE |
| Date Received | 2013-01-14 |
| Returned To Mfg | 2012-12-17 |
| Model Number | D9601 |
| Catalog Number | D9601 |
| Lot Number | 2D04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INC |
| Manufacturer Address | 1502 EAST LAHARPE KIRKSVILLE MO 63501 US 63501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-14 |